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Measurement of Energy Metabolism in Infants (BabyEE Pilot)

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ClinicalTrials.gov Identifier: NCT02683473
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Leanne Redman, Pennington Biomedical Research Center

Brief Summary:
The purpose of this study is to measure energy expenditure during the first 3 months of life in infants.

Condition or disease
Infant Development Infant Overnutrition

Detailed Description:

This study intends to establish the feasibility of undertaking comprehensive metabolic phenotyping in infants. The overarching aim is to complete a prospective assessment of energy expenditure in the new infant metabolic chamber approximately one week apart to determine the accuracy and precision of infant protocols related to energy metabolism (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) and physical activity. This cross-sectional study will answer the following questions:

  1. What is the test re-test reliability of measuring energy expenditure (sleeping metabolic rate, resting metabolic rate, diet-induced thermogenesis) in an infant under the same conditions, 5-7 days apart?
  2. What is the reliability of 24h energy expenditure estimated by the infant metabolic chamber in comparison to a 7-day doubly labeled water study?
  3. How do energy expenditure measurements in infants need to be adjusted to account for variability in infant size and body composition?

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Measurement of Energy Metabolism in Infants: BabyEE Pilot
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Group/Cohort
Infants
Infants aged 1-3 months



Primary Outcome Measures :
  1. Energy Expenditure by infant metabolic chamber [ Time Frame: Approximately 1 week ]
    Energy expenditure by infant metabolic chamber measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.

  2. Energy expenditure by doubly labeled water [ Time Frame: Approximately 1 week ]
    Energy expenditure by doubly labeled water measured over 7 days in infants aged 1-3 months


Secondary Outcome Measures :
  1. Percent body fat [ Time Frame: Approximately 1 week ]
    Percent body fat by PEA POD measured twice about 1 week apart for test re-test reliability in infants aged 1-3 months.

  2. Physical activity counts [ Time Frame: Approximately 1 week ]
    Physical activity counts by Actigraph accelerometer measured over 7 days in infants aged 1-3 months.



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Ages Eligible for Study:   1 Month to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Full-term infants aged 1 to 3 months who are exclusively fed breast milk and/or infant formula will be recruited
Criteria

Inclusion Criteria:

  • Healthy, full-term infant
  • Aged 1 month (28 days) to 3 months (12 weeks, 6 days) at the first visit
  • Exclusively fed breast milk and/or infant formula
  • Willing to accept doubly-labeled water
  • If breastfed, willing to accept pumped breast milk for some of the study procedures

Exclusion Criteria:

  • Unable to complete 2 assessment visits 5-7 days apart at Pennington Biomedical Research Center
  • Unable or unwilling to eat from an infant feeding bottle
  • Born preterm (< 37 weeks gestation)
  • Congenital abnormality or disability
  • Gastric reflux
  • Acute illness within 7 days of the study (fever, diarrhea)
  • Use of medications to treat a chronic condition (does not include use of vitamin supplements or PRN medication for flatulence)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683473


Contacts
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Contact: Abby Altazan, M.S. (225) 763-2801 abby.altazan@pbrc.edu

Locations
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United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Abby Altazan, M.S.    225-763-2801    abby.altazan@pbrc.edu   
Principal Investigator: Leanne M Redman, Ph.D.         
Sub-Investigator: Eric Ravussin, Ph.D.         
Sub-Investigator: Abby Duhé Altazan, M.S.         
Sub-Investigator: Daniel Hsia, M.D.         
Sponsors and Collaborators
Pennington Biomedical Research Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center

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Responsible Party: Leanne Redman, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02683473     History of Changes
Other Study ID Numbers: PBRC 2015-061
P30DK072476-10 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Overnutrition
Infant Nutrition Disorders
Nutrition Disorders